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FDA: Limited benefit with 'tamper-proof' OxyContin

Federal health officials say a new version of the painkiller OxyContin that is designed to be harder to abuse offers some improvements over the original pill.

Purdue Pharma LP has touted the new pill's plastic-like coating, which is designed to make the drug harder to crush and snort or inject.

Food and Drug Administration scientists said Tuesday that the drug's resistance to abuse is "limited," but "may provide an advantage over the currently available OxyContin."

A panel of advisers to the FDA said last year that the company needed to do more testing to demonstrate the drug's tamper resistance.

The FDA will ask the same panel Thursday whether the drug should be approved based on new data submitted by Stamford, Conn.-based Purdue Pharma.

OxyContin, the nation's top-selling prescription painkiller last year with sales of more than $2 billion, was hailed as a breakthrough treatment for severe chronic pain when it was introduced in 1996. A time-release version of the narcotic oxycodone, it was designed for use over 12 hours to keep a steady state of the painkiller in the bodies of seriously ill patients.

However, Oxycontin and similar drugs were quickly adapted by drug abusers who discovered they could get a heroin-like high by crushing the pills and snorting or injecting the entire dose at once.

A federal survey conducted in 2007 found that 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.

The FDA has made a number of public service advisories on the problem with little success, and more recently started pressuring companies to make pain relievers more difficult to abuse.

In August, drugmaker King Pharmaceutical's Embeda became the first painkiller to win FDA approval as a tamper-proof medication.

When Purdue Pharma came before the FDA's panel last year, the company said it planned to offer tamper-proof versions of lower dose OxyContin, while keeping higher doses in their original form.

The FDA panel said that was a bad idea since doctors and physicians might mistakenly assume that all doses had been reformulated.

The company has now said it will make the changes to all doses of the drug.

In documents posted online, Purdue Pharma acknowledged that no formulation "will prevent all methods of tampering that may lead to abuse." But the company says the new version should significantly discourage abuse by making the pills more difficult and more time-consuming to manipulate.

OxyContin was the top-selling prescription painkiller in the U.S. last year with sales of nearly $2.3 billion, according to medical research firm IMS Health. The drug accounts for more than half the market for codeine-derived drugs, which also includes Vicodin and various generic medications.

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Swim knew this was coming, only a matter of time. Really though, what can they really do, make them a "little" harder to crush, addicts will just pound them harder, make them "gel" up, well, this has already been done with other brands, and was successful until people discovered there is a certain temperature that the pill is vulnerable. Adapt the pill, the user will adapt their technique. Really when swim thinks about it, every pill on the market that he can think of that is desirable, is abused, because where there is a will, there is a way. Swims gonna try and open up a can of worms here....chillinwill, would swiy be as so kind to give swim your input on this: Swim thinks that the pharmacies would want there drugs to be abused to a certain point. Does that not mean more money for them? If medications were only given to people who fell perfectly within the standards, prescription pill companies would make no money,well thats a little exagerated, they would make much less money.Swim thinks. Swim believes that purdue lets say for example. The more people that lie cheat and steal to get their pills, (and lets not forget the ones who truly need them because they do exist)the more money the company brings in. The more money the company brings in, the happier the shareholders are, and the more everybody gets paid. So does anybody truly believe that the company "wants" to spend millions of dollars in r&d to make there pills "abuse proof". Swim thinks not, obviously just to satisfye the FDA. This is swims opinion, don't blast swim for voicing this or nothing, its just what he feels, anyone know anyone who cares to elaborate?

BTW, swim is not biast in any way against oxycodone or oxycodone users, so please don't take his post that way, just trying to stir up some discussion on the thread. Thanks, take care

If this stops 1 single person who wants to abuse oxycontin I'd be surprised. 24 hours after the new pills are released the internet will be flooded with ways to break/dissolve/etc. the stupid coating or whatever. If you considering how many hundreds of thousands/millions the company and the FDA wasted fucking around with this concept, all to "annoy" oxycontin users, it is just pathetic and ridiculous.

That is what we..no...our politicians call, THE WAR ON DRUGS...hehehehehe...Swim agrees completly with swiy because swiy agrees with swim..lol..But seriously, swim on one hand swim thinks this more for like a "public eye" type thing, make it look like the government is doing something, but actually, stuff like this rarely even makes the news, or at least swim has never caught it, so that hand is out, and on the other hand all that is left is what swim and swiy has said.."just to annoy drugs users". Swim says there maybe something the pillmakers have thought of that addicts haven't. There very well could be a way to make tablets that would take fair chemistry experiance to extract the oxycodone, but swim thinks the drug would have to contain more than just oxycodone. Swim highly doubts this though, and he also highly doughts this will have any effect what so ever. Could the FDA pull the drug off the line if purdue pharma didn't cooperate? Swim doubts this as well, due to the fact that if they did this to one company, they would have to do this to all. They would have to have a very good reason for pulling a drug off the market would they not? And it would have to be better than just saying" this medication is too easy to abuse". There are many other medications that are the same way, why don't they pick on them? Its not like they have officially "imposed" any guidelines have they? Can they?

Swim thinks that the pharmacies would want there drugs to be abused to a certain point. Does that not mean more money for them? If medications were only given to people who fell perfectly within the standards, prescription pill companies would make no money,well thats a little exagerated, they would make much less money.Swim thinks.

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Hm. A good point. It makes swim wonder, if they really wanted to tackle the issue, they could. Why doesn't the US government just implement far stronger controls on pharmaceutical suppliers, like they do in the UK? Much stricter regulation is applied to pharmaceutical companies here, and all prescriptions of controlled drugs need to be vetted, with stringent control and supervision, both at prescribing and dispensing stages. Yet the companies still make money, don't they?

Swim understands that the main sources of oxycodone (and other commonly abused prescription meds) for "illicit" users are unscrupulous pharmacists, corrupt doctors, prescription forgeries and large-scale theft. The stuff is so widely available, there certainly isn't a shortage of supply: Oxycontin, in particular, appears to have been not only widely distributed, but also aggressively advertised and marketed.

I guess applying the same level of regulation and scrutiny as in the UK is slightly harder to do, due to the fact that the US does not have a nationalised health service, and with the majority of doctors, prescribing physicians and pharmacists working privately. But this doesn't make it impossible.

The one prohibitive factor, swim believes, is the purely commercialised nature of the medical system in the States. Money can buy a huge amount of discretion, when it comes to people turning a blind eye to dubious prescribing practices and prescription pill addiction epidemics.

Here in lies the problem, swim thinks. The whole system is orientated towards making money, not providing the public with much needed, properly scrutinised health care.

Give up. You lost the War on Drugs. Just stop already. I don't want to know how much money went into this incredibly stupid and wholly pointless "tamper-proof" garbage.
Next time you get a hankering for throwing money at a problem, I invite you to visit my cousin's daughter, who is slowly, painfully dying from a brain tumor. I want you to look that little girl in the eye and tell her that her life is not as important as putting a plastic coating on a tablet to prevent people from having fun with it.